Kornimate/medical-research-clean huggingface dataset:
electroretinogram in autistic spectrum disorders

Conditions: Autism Spectrum Disorder

Summary: this study aims to find out the incidence of a reduced light adapted electroretinogram (erg) b-wave amplitude in children with a diagnosis of autism spectrum disorders (asd).

autism spectrum disorder (asd) is a neurodevelopmental condition which becomes apparent as children grow. children with asd are slow to develop language and have problems interacting socially with others. it is not clear why asd occurs, but there is some evidence that the signals that tell the brain how to grow are altered which causes the brain to develop and function differently in people with asd. eyes develop from the same embryonic tissue as the brain. this means that the retina, which is the light sensitive layer at the back of the eye, shares the same signals as the brain. investigators can listen to retinal signals outside the eye and the retina can, in this way, act as an accessible part of the brain. the investigators will detect retinal signals as electrical messages. sensors placed near the eye pick up the electrical changes in the retina each time a light flashes. this non-invasive, routine clinical test is called an electroretinogram, (erg). the investigators have carried out a study that showed differences in the ergs recorded from adults with asd compared to control participants. the main aim of this project is find out how common erg differences are in children with asd compared to controls. if it is common, investigators could use the erg to make an earlier diagnosis of asd and help families sooner. it could help investigators better understand the way the asd brain signals and give investigators a way of measuring if therapies work.

Eligibility criteria:
inclusion criteria: * cohort 1: individuals with diagnosis asd with an iq measure exceeding 85 * cohort 2: typically developed controls without diagnosis of asd exclusion criteria: * a history of eye disease or treatment or seizure medicines that may alter retinal function

Keywords: electroretinogram
imaging of arthropathy in boys with hemophilia in china

Conditions: Hemophilia

Summary: hemophilia is a genetic condition characterized by marked phenotypic heterogeneity. bleeding into a joint is the single most important risk factor for the development of hemophilic arthropathy (ha). it is thought that clinical and imaging manifestations of ha are at least partially attributable to genetic polymorphisms unrelated to the hemophilia genotype. identifying and characterizing biologic factors that could explain differences in susceptibility to joint degeneration of patients with hemophilia would help stratify patients according to the risk of degeneration of their joints and develop personalized therapeutic and prophylactic strategies. this study is conducted in china.

this will be a 3-year prospective cohort study conducted in a single centre (beijing children's hospital, bch, china) with a 2-year follow-up of patients index joints (ankles, elbows and knees) of young chinese boys with hemophilia a will be evaluated as follows: physical examination every 6 months using the hemophilia joint health score \[hjhs\], ultrasound imaging (gray-scale and color doppler ultrasound \[us\]), and by laboratory (serum) at baseline, at 6, and 24 months. magnetic resonance imaging (mri) scans of index joints will be obtained at baseline, and 24 months. features that will be captured either quantitatively or semantically in the imaging scans will be aggregated to generate "imaging phenotypes" which will be associated with clusters of co-expressed genes (metagenes) and clinical data.

Eligibility criteria:
inclusion criteria: * hemophilia a with baseline fviii levels of \<2% * clinical history of ≥ 50 exposure days to fviii prior to the study start. * on-demand treatment, prophylaxis fviii infusions or treatment with plasma-derived products for \>3 months prior to enrollment into the study. exclusion criteria: * history of fviii inhibitor (titer \>0.6 bethesda units \[bu\]) * chronic renal failure (serum creatinine \>2.0 mg /dl). * chronic liver disease (alanine aminotransferase \[alt\] \>200 u/l). * clinically documented immunodeficiency. * anticipation of need for major surgery during the study period. * association of diseases known to mimic or cause joint diseases such as symptomatic human immunodeficiency virus (hiv) infection, juvenile idiopathic arthritis, and metabolic bone diseases. * social barriers for participation in the study such as long distance between home and the comprehensive care centre, and documented track record of non-compliance to therapies or participation in clinical studies. * neuro-developmental/behavioral problems. * contraindications to mr imaging (presence of heart pacemakers, metallic foreign bodies in the eye, aneurysm clips, severe claustrophobia).

Keywords: hemophilia radiogenomics arthropathy
efficacy and safety of tofacitinib in subjects with active ankylosing spondylitis (as)

Conditions: Ankylosing Spondylitis

Summary: the purpose of this study is to determine if tofacitinib is safe and effective in subjects with active ankylosing spondylitis.


Eligibility criteria:
inclusion criteria: * has a diagnosis of ankylosing spondylitis (as) based on the modified new york criteria for as (1984). * must have a radiograph of si joints (ap pelvis) documenting diagnosis of as. * has active disease despite nonsteroidal anti-inflammatory drug (nsaid) therapy or intolerant to nsaids. exclusion criteria: * history of known or suspected complete ankylosis of the spine. * history of allergies, intolerance or hypersensitivity to lactose or tofacitinib. * history of any other rheumatic disease. * any subject with condition affecting oral drug absorption.
feasibility & implementation of a plant-based weight-loss program in an office-based setting

Conditions: Weight Loss; Blood Pressure; Lipid Disorder; PreDiabetes; Diabete Mellitus

Summary: this prospective study aims to assess the feasibility and implementation of a plant-based, weight-loss program in an office setting. the study will also assess changes in body weight, blood pressure, plasma lipids, glycated hemoglobin, and body composition with a 12-week, plant-based, weight-loss program. these health benefits may illustrate feasibility to physicians and healthcare professionals elsewhere.

this will be a prospective interventional study to evaluate the feasibility, implementation and efficacy of 12-week plant-based, weight-loss program that is carried out in an office setting and is open to participation to the general public via local print and online advertising or whichever methods apply. the program will include weekly education and support, and assessment of blood pressure, lipids, hemoglobin a1c, and body composition before and after starting the program. the price of the program, $645, will cover the costs of weekly education, blood pressure check, laboratory testing and body composition analysis.

Eligibility criteria:
inclusion criteria: * men and women age ≥18 years of age exclusion criteria: * use of recreational drugs in the past 6 months * pregnancy or intention to become pregnant during the study period, as verified by self-report * unstable medical or psychiatric illness * lack of english fluency * inability to maintain current medication regimen * inability or unwillingness to participate in all components of the study

Keywords: weight loss body composition lipids hemoglobin a1c blood pressure
effect of dapagliflozine on systemic and renal endothelial function

Conditions: Endothelial Function; Type 2 Diabetes

Summary: this is a phase 4, single center, randomized, open-labeled, cross-over design study. the primary objective of the study is to compare effect of dapagliflozine and metformin on endothelial function. subjects are randomized to initial metformin or initial dapagliflozin group and maintained initial treatment for 8 weeks. during that period, dose of dapagliflozin is maintained 10mg/day and metformin can be titrated upto 2000 mg/day. after 1 weeks of washout period, 8 weeks' cross-over is followed.


Eligibility criteria:
inclusion criteria: 1. present with type 2 diabetes based on the disease diagnostic criteria as described by the world health organization (who) 2. treated with diet and exercise alone for recent 3 months 3. aged 20-80 years 4. hba1c 7\~9% 5. this inclusion criterion applies to females of childbearing potential (not surgically sterilized and between menarche and 1-year postmenopause) only. * are not breastfeeding. * test negative for pregnancy at the time of screening based on a blood serum pregnancy test. * intend not to become pregnant during the study. exclusion criteria: 1. previous history of ihd or brain infarct 2. having typical anginal pain or atypical chest pain with dyspnea 3. modification of diet in renal disease (mdrd) estimated gfr≥60 ml/min

Keywords: sglt2 inhibitor
laparoscopic surgery in elderly patients

Conditions: Uterine Prolapse

Summary: the primary purpose is to evaluate the quality of post-operative recovery and post-operative pain in elderly patients (more than 75 years) who undergo laparoscopic surgery for uterine prolapse.

previous randomized clinical trial (nct01887028) showed that the combined use of a low intraperitoneal pressure and a warmed, humidified co2 gas resulted in better clinical outcomes (better quality of post-operative recovery and less post-operative pain) in patients aged 45-75 years, who underwent laparoscopic surgery for uterine prolapse. quality of post-operative recovery is very important in elderly patients. investigators hypothesize that the combined use of a low intraperitoneal pressure and a warmed, humidified co2 gas may also result in better clinical outcomes. in this observational clinical trial, quality of post-operative recovery by qor-40, post-operative pain by visual analog scale, intra or postoperative complications and intraoperative core temperature are evaluated in elderly patients (more than 75 years old) who undergo laparoscopic surgery for uterine prolapse. investigators use a low intraperitoneal pressure (6 mmhg) and a warmed, humidified co2 gas during laparoscopy. these outcomes will be compared with those of previous randomized clinical trial.

Eligibility criteria:
inclusion criteria: * age more than 75 years old * patients undergoing laparoscopic promontofixation with or without sub-total hysterectomy for uterine prolapse * asa class i or ii exclusion criteria: * bmi more than 30 * height less than 150cm

Keywords: carbon dioxide pneumoperitoneum intraperitoneal pressure post-operative recovery laparoscopic humidification system
three-arm study of the safety and efficacy of pirfenidone in patients with idiopathic pulmonary fibrosis

Conditions: Idiopathic Pulmonary Fibrosis

Summary: the objectives of this study are to assess the safety and efficacy of treatment with pirfenidone 2403 milligrams per day (mg/d) compared with placebo in patients with idiopathic pulmonary fibrosis (ipf), to assess the safety and efficacy of treatment with pirfenidone 1197 mg/d in patients with idiopathic pulmonary fibrosis and to characterize the pharmacokinetic disposition of pirfenidone in patients with idiopathic pulmonary fibrosis.

this is a phase 3, randomized, double blind, placebo-controlled, three-arm, safety and efficacy study of pirfenidone in patients with idiopathic pulmonary fibrosis. approximately 400 patients at approximately 70 centers will be randomly assigned (2:2:1) to receive either 2403 milligrams (mg) of pirfenidone, placebo equivalent, or 1197 mg of pirfenidone administered in divided doses three times per day (tid) with food. patients will be randomized by geographic region. patients will receive blinded study treatment from the time of randomization until the last patient randomized has been treated for 72 weeks. a data monitoring committee (dmc) will periodically review safety and efficacy data to ensure patient safety. after week 72, patients who meet the progression of disease (pod) definition, which is a ≥ 10% absolute decrease in percent predicted fvc or a ≥ 15% absolute decrease in percent predicted carbon monoxide diffusing capacity (dlco), will be eligible to receive permitted ipf therapies in addition to their blinded study drug. permitted ipf therapies include corticosteroids, azathioprine, cyclophosphamide and n-acetyl-cysteine (with restrictions).

Eligibility criteria:
primary inclusion criteria: * diagnosis of idiopathic pulmonary fibrosis * 40 to 80 years of age * forced vital capacity greater than or equal to 50% predicted value * carbon monoxide diffusing capacity greater than or equal to 35% predicted value * either forced vital capacity or carbon monoxide diffusing capacity less than or equal to 90% predicted value * no improvement in past year * able to walk 150 meters in 6 minutes and maintain saturation greater than or equal to 83% while on no more than 6 liters per minute (l/min) supplemental oxygen primary exclusion criteria: * unable to undergo pulmonary function testing * evidence of significant obstructive lung disease or airway hyper-responsiveness * in opinion of investigator patient is expected to need and be eligible for a lung transplant within 72 weeks after randomization * active infection * liver disease * cancer or other medical condition likely to result in death within 2 years * diabetes * pregnancy or lactation * substance abuse * personal or family history of long qt (q wave,t wave) syndrome * other ipf treatment * unable to take study medication * withdrawal from other ipf trials

Keywords: idiopathic pulmonary fibrosis lung pirfenidone intermune
ovarian laparoscopic in vivo activation of ovary for premature ovarian insufficiency

Conditions: Primary Ovarian Insufficiency

Summary: the oliva device will enable to perform shallow slashes on the ovarian cortex in patients undergoing oophorectomy. prior to the resection of the ovary from the pedicle we will perform 5 parallel slashes 3 cm long. following oophorectomy investigation by the pathologist as to the depth of cuts and proximity to blood vessels and later.

the oliva device is built of 5 parallel razor blades enclosed by protective cap

Eligibility criteria:
inclusion criteria: * peri/menopausal women undergoing laparoscopic oophorectomy exclusion criteria: * women with ovarian malignancy * women with polycystic ovarian syndrome

Keywords: primary ovarian insufficiency in-vivo activation
aromatase inhibitors, alone and in combination with growth hormone in adolescent boys with idiopathic short stature

Conditions: Idiopathic Short Stature

Summary: when treating very short children in puberty we are time-limited, as sex hormones cause the growth plates to fuse and growth to end. growth hormone (gh), plus drugs that stop puberty, increase height potential, but leave children sexually infantile at a critical time in development. human and animal data show that estrogen, in females and males, is a principal regulator of the fusion of the growth plate in puberty. using aromatase inhibitors (ais), which block testosterone to estrogen conversion, in boys with different growth disorders, we have shown that ais may have beneficial effects enhancing height potential in growth-retarded males, without affecting their puberty. however, no direct comparison of the effect of ais alone vs. conventional gh treatment has been done to date. this study will assess the effect of ais alone, gh alone and combination treatment in enhancing height potential in adolescent boys with idiopathic short stature.


Eligibility criteria:
inclusion criteria: * males: ages: 12 - less than 18 years. * bone age less than 14 ½ years at study initiation. * presence of puberty. * idiopathic short stature will be defined as a short child equal or less than -2sd for height, with normal gh responses to stimuli (\> or = 5ng/ml to at least 2 secretagogues) or a normal igf-i and bp-3, normal body proportions and no other identifiable growth pathology. * accurate growth data for at least 6 months at baseline is available. exclusion criteria: * chronic illnesses. * chronic use of glucocorticosteroids. * previous use of hormonal treatment with ais, sex steroids or gh in the preceding 6 months. * birth weight small for gestational age (sga).

Keywords: aromatase growth letrozole anastrozole gh children puberty
pupillary dilation reflex (pdr) evaluation during general anesthesia

Conditions: Pain

Summary: in this study, the pupillary dilation reflex is measured as a nociceptive indicator during elective abdominal surgery under general anesthesia.

an infrared camera of the video pupillometer measures the pupillary dilation reflex (pdr) in response of a nociceptive stimulus. this autonomic reflex, parasympathetic mediated in sedated patients, can be generated by various pain stimuli (built in standardized protocol, surgical incision, ...) the pdr is a robust reflex, even in patients under general anesthesia, and provides a potential evaluation of the autonomous circuit within the nociceptive evaluation based on pupil dilation upon a-delta and c fibers in both electrical or mechanic stimulation. this mono-centric project involving american society of anesthesiologists (asa) classification i-ii patients undergoing elective abdominal surgery under general anesthesia are recruited. enrolled patients perioperative undergo pdr measurements at four different standardized times.

Eligibility criteria:
inclusion criteria: * scheduled abdominal surgery * asa i-ii exclusion criteria: * history of eye deformity, invasive ophthalmologic surgery, impaired pupil reflex in advance * kown cranial nerve(s) deficit * infection of the eye * predicted difficult airway management (daf guidelines) * chronic opioid use (\>3 months) * ongoing treatment with beta-blockers, dopamine antagonists, topical atropine

Keywords: heart rate reflex, pupillary monitoring, intraoperative
shanghai pediatric cataract study

Conditions: Pediatric Cataract; Congenital Cataract; Traumatic Cataract; Visual Outcome; Genetic Anticipation

Summary: the purpose of this study is to evaluate the long-term visual outcome of the cataract surgery using a large-scale and comprehensive database of pediatric cataract participants, including congenital and traumatic cataract. the investigators will further investigate into the various genetic and environmental factors that may contribute to the pathogenesis of pediatric cataract.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of pediatric cataract * must be able to cooperate with the ophthalmic examination exclusion criteria: * clinical diagnosis of mental illness * mentally disabled
a comparison of two multi-drug therapies in hiv-infected patients who have never received anti-hiv treatment

Conditions: HIV Infections

Summary: the purpose of this study is to compare 2 combination drug therapies in hiv-infected patients who have never received anti-hiv treatment.

in this open-label study antiretroviral-naive patients are randomized to one of two drug regimens: arm i: 141w94 (amprenavir), 1592u89 (abacavir), and combivir (3tc/azt tablet). arm ii: nelfinavir and combivir.

Eligibility criteria:
inclusion criteria patients must have: * cd4 count \> 50. * hiv rna \> 5,000. * no active aids (excluding cd4 count \< 200). * ability to comply with dosing schedule and protocol evaluations. prior medication: allowed: * 3tc or any protease inhibitor, if \< 1 week of therapy. * other nucleoside analogs, if \< 4 weeks of therapy. exclusion criteria co-existing condition: patients with any of the following symptoms or conditions are excluded: * active aids (not including cd4 count \< 200). * malabsorption syndrome affecting drug absorption. concurrent medication: excluded: enrollment in any other investigational drug protocol. prior medication: excluded: non-nucleoside reverse transcriptase inhibitors.

Keywords: drug therapy, combination hiv protease inhibitors vx 478 reverse transcriptase inhibitors anti-hiv agents abacavir
n-acetyl glucosamine as therapeutic intervention for coronavirus disease-19 (covid-19)

Conditions: Coronavirus; Covid19

Summary: this study examines the efficacy of n-acetylglucosamine (nag) in treating patients with novel coronavirus (covid-19) infection.

this is a single center, prospective, observational cohort study. a total of 150 cases who test positive for the novel coronavirus (covid-19) will be recruited. presenting to the emergency room of the study site, these cases will be treated with n-acetylglucosamine (nag) in 700 mg doses every 12 hours as first-line treatment for 30 days. standard of care (e.g., remdesivir approved for emergency use in severe cases, ventilator for patients with respiratory failure, etc.) will be provided based on the patient's clinical needs, which will be at the discretion of the treating physician. upon admission, the research team will record patient demographics, comorbidities, symptoms, disease severity (as assessed by the world health organization ordinal scale for clinical improvement), need for supplemental oxygen, and time from symptom onset until hospital arrival. the research team will also collect bloodwork for the following at admission: white blood cell count (wbc), hematocrit (hct), hemoglobin (hbg), c-reactive protein (crp), procalcitonin (pct), interleukin-6 (il-6), and erythrocyte sedimentation rate (esr). during the study period, discretionary treatments and interventions will be recorded daily until study exit. the primary outcomes of interest are rate of intubation, hospital length of stay, and mortality. secondary outcomes of interest include intensive care unit (icu) admission, icu length of stay (los), supplemental oxygen duration, rate of hospice initiation, and poor clinical outcome (defined as combined death/hospice initiation).

Eligibility criteria:
inclusion criteria: * ≥18 years old * treated with n-acetyl glucosamine (nag) as first-line treatment * present with coronavirus disease 2019 (covid-19) symptoms (including but not limited to fever, cough, shortness of breath, sore throat, nasal congestion, malaise, headache, muscle pain, loss of taste and/or smell, diarrhea, and vomiting) * clinically diagnosed with covid-19 by reverse transcription polymerase chain reaction (rt-pcr) * no intubation prior to hospitalization and enrollment in the current study. exclusion criteria: * \<18 years old upon admission * allergy to nag * allergy to shellfish * currently taking warfarin * currently pregnant or lactating

Keywords: n-acetyl glucosamine